Torasemide BE Study EU [Design Issues]

posted by pmohite – India, 2020-06-22 13:25 (1399 d 02:35 ago) – Posting: # 21559
Views: 1,616

Dear Team,

Currently, we are working on BE study planning of Torasemide molecule for EU with strength as 5 mg, 10 mg, 20 mg, 50 mg, 100 mg and 200 mg. Of which, there is dose proportionality between 5 mg, 10 mg and 20 mg and dose proportionality between 50 mg, 100 mg and 200 mg.

As per the EU guidance, If several strengths of a test product are applied for, it may be sufficient to establish bioequivalence at only one or two strengths, depending on the proportionality in composition between the different strengths. The strength(s) to evaluate depends on the linearity in pharmacokinetics of the active substance. The bioequivalence study should in general be conducted at the highest strength. For products with linear pharmacokinetics and where the drug substance is highly soluble, selection of a lower strength than the highest is also acceptable. Selection of a lower strength may also be justified if the highest strength cannot be administered to healthy volunteers for safety/tolerability reasons.

As per FDA OGD for Torsemide “Due to safety concerns associated with administering Torasemide Tablets, 100 mg, to healthy subjects, in-vivo bioequivalence studies should be conducted on the 20 mg strength”.

Based on above discussion, can we go with 20 mg BE study and 50 mg BE study and get biowaiver for other strengths.


Edit: Category changed; see also this post #1[Helmut]

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